James D. Colandene

Characterization of Subvisible Particle Formation During the Filling Pump Operation of a Monoclonal Antibody Solution

Arpan Kumar Nayak, James D. Colandene, Victor Bradford et al. · Journal of Pharmaceutical Sciences · 2011 · 95 citations

Engineering, Medicine, Filling Pump Operation +9

Lyophilization Cycle Development for a High-Concentration Monoclonal Antibody Formulation Lacking a Crystalline Bulking Agent

James D. Colandene, Linda M. Maldonado, Alma T. Creagh et al. · Journal of Pharmaceutical Sciences · 2006 · 88 citations

Engineering, Lyophilization Cycle Development, Biotechnology +7

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Tapan K. Das, Alavattam Sreedhara, James D. Colandene et al. · Journal of Pharmaceutical Sciences · 2021 · 28 citations

Engineering, Medicine, Drug Manufacture +11

Unexplored benefits of controlled ice nucleation: Lyophilization of a highly concentrated monoclonal antibody solution

Shubhadra N. Singh, Swati Kumar, Valeriy Bondar et al. · International Journal of Pharmaceutics · 2018 · 21 citations

Immunocytochemical Technique, Natural Sciences, Medicine +7

Syringe Filling of High-Concentration mAb Formulation: Slow Suck-Back Pump Speed Prevented Filling Needle Clogging

Simon Hanslip, Kashappa Goud H. Desai, Mark Palmer et al. · Journal of Pharmaceutical Sciences · 2017 · 17 citations

Medicine, Biomedical Engineering, High-concentration Mab Formulation +1